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Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction (S-1 adjuvant)

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ClinicalTrials.gov Identifier: NCT02564367
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
Nordic Pharma SAS
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE October 6, 2015
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
number of patients with discontinuation of S-1 due to intolerable adverse reactions [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • One-year relapse-free survival rate [ Time Frame: 12 months ]
    Mo local relapse or distant metastases within one year after start of adjuvant treatment
  • Relapse-free survival [ Time Frame: 2 years ]
    relapse-free survival until end of study
  • Quality of life [ Time Frame: 12 months ]
    European Organisation for Research and Treatment of Cancer (EORTC) C30 questionnaires
  • One-year survival rate [ Time Frame: 1 years ]
  • Overall survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2015)
  • plasma concentration of Tegafur (FT) [ Time Frame: 12 months ]
    To evaluate the pharmacokinetics of FT
  • plasma concentration of 5-Fluorouracil (5-FU) [ Time Frame: 12 months ]
    To evaluate the pharmacokinetics of 5-FU
  • plasma concentration of Gimeracil (CDHP) [ Time Frame: 12 months ]
    To evaluate the pharmacokinetics of CDHP
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction
Official Title  ICMJE Multicenter Phase I/II Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction
Brief Summary

Multicenter trial in Germany:

Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the feasibility and tolerability of adjuvant S-1 treatment in Caucasian patients and to determine the recommended dose for the treatment regimen.

Detailed Description

Patients will be enrolled in one cohorts.

Cohort 1 consists of 30 patients who receive S-1 twice daily for 18 cycles (D1-14 q 3 wks).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma,Stomach
  • Adenocarcinoma, Esophagogastric Junction
Intervention  ICMJE Drug: S-1

18 cycles S-1, orally administered twice daily D1-14, q 3 wks

S-1 starting dose: 2 x 30 mg/m^2 body surface area (BSA), D1-14, q 3 wks First dose reduction: 2 x 25 mg/m^2 BSA, D1-14, q 3 wks Second dose reduction: 2 x 20 mg/m^2 BSA, D1-14, q 3 wks

Other Name: Teysuno
Study Arms  ICMJE Experimental: Treatment

First Cohort 1:

(n = 30 patients) 18 cycles S-1

Intervention: Drug: S-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
60
Actual Study Completion Date  ICMJE March 6, 2020
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient signed and dated informed consent before the start of any specific protocol procedures
  2. Adult Caucasian patients ≥ 18 years of age
  3. Histologically confirmed diagnosis of adenocarcinoma of the stomach and esophagogastric (EG) junction classified as uT2/uT3/uT4, any N category, M0 or any uT, N+, M0 patient (for patients having received neoadjuvant chemotherapy) or pT2/pT3/pT4, any N category, M0 or any pT, N+, M0 (for patients having received primary surgery) according to Union international contre le cancer (UICC) TNM edition 7.
  4. R0-resection after neoadjuvant treatment. However, patients can also be included if neoadjuvant treatment could not be performed due to medical indication of primary surgery (perforation, bleeding etc.) or was not performed due to understaging.
  5. D2 lymph node dissection performed
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  7. Consent to translational research being performed on tumor tissue of the primary tumor that had been removed during the resection surgery. Translational research will be performed only upon completion of routine histological and pathological evaluations of the tumor
  8. Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 6 months after last application of S-1.

    Females of childbearing potential (FCBPs) should be included after a confirmed menstrual period (only if applicable, i.e. still having menses) and must have a negative highly sensitive pregnancy test within 7 days prior to the first application of study treatment and must agree to use highly effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 6 months after last application of S-1.

    Such highly effective birth control methods include:

    • oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation
    • oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation
    • intrauterine device
    • intrauterine hormone-releasing system
    • bilateral tubal occlusion
    • commitment to complete abstinence from heterosexual contact

    A female subject following menarche is considered to be of childbearing potential unless she is naturally amenorrhoeic for ≥ 1 year without an alternative medical reason, or unless she is permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy).

  9. Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of S-1 and must agree to use condoms during the course of the trial and for at least 6 months after last administration of S-1 in case of sexual intercourse with FCBP or pregnant female.
  10. Patient must be able to take medication orally within eight weeks after surgery at the start of S-1.
  11. Normal cardiac function demonstrated by Electrocardiogram (ECG) and echocardiogram (LVEF ≥ 55%)
  12. Adequate bone marrow, hepatic and renal function defined as

    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
    • Haemoglobin ≥ 9 g/dL
    • Platelets ≥ 100 x 10^9/L
    • Albumin ≥ 2.5 g/dL
    • Total bilirubin ≤ 2 mg/dL
    • GOT/AST and GPT/ALT ≤ 3 x Upper normal limit (ULN)
    • Calculated creatinine clearance according to MDRD equation ≥ 50 mL/min
  13. Patient's legal capacity to consent to study participation

Exclusion Criteria:

  1. Metastatic disease (exclusion of metastatic disease by a postoperative CT or MRI scan of thorax and abdomen within 3 weeks prior to start of adjuvant therapy)
  2. Polyneuropathy > grade 1 (NCI CTCAE version 4.0)
  3. Evidence of ascites or liver cirrhosis
  4. Patient is pregnant or breast-feeding
  5. Patient underwent a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or there is an anticipated need for major surgical procedure during the course of the study.
  6. Heart failure ≥ NYHA functional classification system grade 2
  7. Myocardial infarction, unstable angina, cardiac angioplasty or stenting procedure within the last 6 months.
  8. Medical history of pulmonary fibrosis or interstitial lung disease (ILD)
  9. Active or uncontrolled bacterial, viral, or fungal infection that requires systemic treatment
  10. Known HIV-, HBV-, and HCV-infection
  11. Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety.
  12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  13. Any cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) after resection surgery or requirement for concurrent cancer treatment during study treatment with S-1.
  14. Participation in another clinical trial or treatment with an investigational drug after surgery and during study treatment with S-1.
  15. Known immediate or delayed hypersensitivity to any of the active substances of S-1 (tegafur, gimeracil, and oteracil) or to any of the excipients or to drugs chemically related to S-1 (e.g. 5-fluorouracil)
  16. History of severe and unexpected reactions to fluoropyrimidine therapy
  17. Known dihydropyrimidine dehydrogenase (DPD) deficiency
  18. Treatment with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine within 4 weeks before start of study drug or during study treatment
  19. Previous or concurrent malignant tumor disease other than underlying tumor disease with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
  20. Known alcohol abuse or drug addiction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02564367
Other Study ID Numbers  ICMJE GMBH-STO-0114
2014-004116-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE
  • Nordic Pharma SAS
  • Taiho Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Volker Heinemann, Prof. Dr. Klinikum der Universität München, Campus Großhadern
PRS Account AIO-Studien-gGmbH
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP